Prognosis of Trigeminal Neuralgia When Enrolled in a Multidisciplinary Management Program

NCT ID: NCT03838393

Last Updated: 2019-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

186 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-05-31

Study Completion Date

2015-12-31

Brief Summary

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Background: Prognosis of medically treated trigeminal neuralgia patients is assumed to be poor, but the evidence is lacking. Thus, prospective real-life studies of medical management of trigeminal neuralgia are warranted.

Methods: Observational study. Patients were consecutively enrolled in a structured management program at a specialist centre for facial pain. Optimisation of medical treatment, physiotherapy, psychotherapy, and advice from trained nurses, were parts of the program. Medically intractable patients were referred for neurosurgery. Data-collection was prospective using standardised schemes and patient surveys. The aim was to describe the two-year outcome of medical treatment at the specialist centre. The primary outcome was a 50% reduction in the overall burden of pain according to a Numerical Rating Scale (NRS) after two years.

This study aimed to provide evidence concerning the real-life efficacy of medical management of trigeminal neuralgia (TN) when directed by specialists. The investigatgors hypothesised that the two-year prognosis in a group of medically managed TN patients enrolled in a structured multidisciplinary management program was favourable, defined as a 50 % reduction of the overall burden of pain over a two-year period

Detailed Description

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Conditions

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Trigeminal Neuralgia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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multidisciplinary management

pharmacological and non.pharmacological treatment (specially trained nurses, psychologists and physiologists)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. recordings of the intensity of pain at enrolment of the programme (baseline recording),
2. a two-year assessment (end-point recording),
3. recording of effect and side-effects of drug treatment (at baseline and endpoint).

Exclusion Criteria

1. initiation of medical treatment at the DHC before May 2012,
2. neurosurgical treatment of TN within the two-year follow-up
3. incomplete two-year follow-up
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Danish Headache Center

OTHER

Sponsor Role lead

Responsible Party

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Tone Heinskou

medical doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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Heinskou TB, Maarbjerg S, Wolfram F, Rochat P, Brennum J, Olesen J, Bendtsen L. Favourable prognosis of trigeminal neuralgia when enrolled in a multidisciplinary management program - a two-year prospective real-life study. J Headache Pain. 2019 Mar 4;20(1):23. doi: 10.1186/s10194-019-0973-4.

Reference Type DERIVED
PMID: 30832577 (View on PubMed)

Other Identifiers

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H-1-2012-093

Identifier Type: -

Identifier Source: org_study_id

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